When starting a clinical trial, patient data is everything. But how you collect that data can make or break the success of your study.
Electronic Patient-Reported Outcomes (ePRO) have become a powerful tool in clinical research, allowing patients to report on symptoms, quality of life, or treatment effects in real time. Yet for many teams just getting started, one question stands out:
What should go in your first ePRO form?
This post outlines the essential elements for building a clear, compliant, and user-friendly ePRO form from day one.
Why ePROs matter
Before diving into structure, let’s recap why ePROs are important.
Unlike clinician-reported outcomes, ePROs give you insights directly from the patient’s perspective. They’re especially valuable in trials assessing subjective measures like pain, fatigue, mood or daily function.
By digitising this process, you:
- Improve data accuracy and completeness
- Reduce transcription errors
- Increase patient engagement and adherence
- Get real-time access to data for faster decisions
1. Keep it relevant
Only ask questions that align with the primary and secondary endpoints of your trial. Every item in your ePRO form should serve a purpose, whether it’s to support efficacy analysis, safety monitoring or patient experience.
Avoid adding too many exploratory items in your first version. A short, targeted form is more likely to maintain patient engagement.
2. Make it understandable
Patients may have no medical background. That’s why clarity is critical.
- Use plain language
- Avoid medical jargon
- Include examples when asking about symptoms
- Use intuitive rating scales (e.g., 0–10 pain scale, Likert scales)
Test your form with non-specialists if possible, this helps ensure it’s clear and accessible to your real users.
3. Ensure logical flow
An effective ePRO form is more than just a list of questions.
Structure it with:
- Introductory text that explains the purpose
- Grouped sections by topic (e.g., symptoms, daily activities, medication side effects)
- Consistent answer formats
- Smart skip logic, if your system allows it (e.g., skip questions about pain meds if no pain is reported)
This improves the user experience and makes the data easier to analyse.
4. Don’t forget compliance
Your ePRO tool and forms must meet regulatory and ethical standards, including:
- Informed consent for data collection
- Data privacy and security (GDPR, HIPAA, etc.)
- Audit trails and traceability
- Validation of digital instruments where required
If you’re using a validated questionnaire (e.g., EQ-5D, PHQ-9), make sure to follow licensing and formatting rules.
5. Test before you launch
Once your draft is ready, pilot it with a small group of users, ideally patients similar to your study population. Collect feedback on usability, readability and technical issues.
This stage is essential to catch issues early and build confidence in your data quality.
Xolomon: making research accessible
Your first ePRO form doesn’t need to be complex, it needs to be clear, focused, and patient-friendly. At Xolomon, we help research teams build ePRO forms that are fully integrated into their workflows, ready for remote access, and aligned with their trial goals.
Because the best patient-reported data comes from patients who understand, trust, and engage with your forms.
